Recruiting NA Coronary Artery Disease

New treatment option for Coronary Artery Disease

Official title The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)

ClinicalTrials.gov ID: NCT05427370

What this study is testing

What it's testing
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH3C) trial is a prospective, unblinded, international multi-center randomized trial of 754 subjects enrolled in approximately 45 centers comparing revascularization by percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) in patients with multivessel/left main (LM) coronary artery disease (CAD) and reduced left ventricular ejection fraction (LVEF).
  • Time commitment: about 7 years
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age \>18 years;
  • LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
  • Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant...
  • The institutional Heart Team agrees that guideline-directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed...
  • Signed informed consent.

You likely can't join if

  • Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device...
  • Recent (\<4 weeks) ST-elevation MI;
  • Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
  • Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
  • Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
  • Prior cardiac surgery;
See the full eligibility criteria
Who can join
  • Age \>18 years;
  • LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
  • Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant coronary stenosis is defined as ≥ 70% based on coronary angiography...
  • The institutional Heart Team agrees that guideline-directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or...
  • Signed informed consent.
What rules you out
  • Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization;
  • Recent (\<4 weeks) ST-elevation MI;
  • Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
  • Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
  • Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
  • Prior cardiac surgery;
  • Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
  • Circumstances likely to lead to poor treatment adherence;
  • Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years;
  • Current pregnancy;
  • Patient not amenable to both CABG or PCI according to the Heart Team;
  • Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome.

The study team makes the final eligibility decision.

Where it's taking place

  • Los Angeles, California, United States
  • New Haven, Connecticut, United States
  • Louisville, Kentucky, United States
  • Baltimore, Maryland, United States
  • Rochester, Minnesota, United States
  • Cleveland, Ohio, United States
  • Vienna, Austria
  • São Paulo, Brazil
  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • New Westminster, British Columbia, Canada
  • Vancouver, British Columbia, Canada
  • Winnipeg, Manitoba, Canada
  • Halifax, Nova Scotia, Canada
  • Hamilton, Ontario, Canada
  • London, Ontario, Canada
  • Newmarket, Ontario, Canada
  • Ottawa, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada

+ 19 more site(s).

Compensation & support

A stipend or compensation may be offered.

Compensation likely.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 7 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Los Angeles, California, United States; New Haven, Connecticut, United States; Louisville, Kentucky, United States; Baltimore, Maryland, United States; Rochester, Minnesota, United States; Cleveland, Ohio, United States and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.